Kornimate/medical-research-clean huggingface dataset:
comparison between standard deep anterior lamellar keratoplasty (s-dalk) and intralase enabled deep anterior lamellar keratoplaty (ie-dalk)

Conditions: DALK Corneal Transplant; Keratoconus; Scar

Summary: a prospective comparison between standard deep anterior lamellar keratoplasty (s-dalk) performed manually using a blade (trephine) and femtosecond laser-enabled deep anterior lamellar keratoplasty (ie dalk), where incisions are performed using the femtosecond laser.

even though corneal transplants have been around for more than 100 years, and tools to improve their surgical technique keep getting perfected, both regular and irregular postoperative astigmatism continue to be major concerns in achieving predictable visual results. femtosecond laser technology allows for the creation of more precise incisions with more reproducible patterns, which could lead us to believe that astigmatism management and visual results should be improved with this technology. this would be the first study to prospectively analyze standard versus femtosecond laser-enabled deep anterior lamellar keratoplasties in order to elucidate their relative advantages in the quest for a gold standard.

Eligibility criteria:
inclusion criteria: * age between 18 and 70 years * either advanced keratoconus or corneal scarring requiring a deep anterior lamellar keratoplasty exclusion criteria: * previous keratoplasty * advanced glaucoma * any other retinal or optic nerve pathology that could potentially affect visual outcome * strabismus or amblyopia * significant limbal stem cell deficiency (invlolving \> 3 limbal clock hours) * active autoimmune disease.
a study to evaluate axr-159 ophthalmic solution in patients with dry eye disease

Conditions: Dry Eye

Summary: protocol axr201701 is a multicenter, double-masked, vehicle-controlled, randomized, parallel group study carried out in 2 stages (stage 1: axr-159 ophthalmic solution (30 mg/ml or 50 mg/ml); stage 2: axr-159 ophthalmic solution (3 mg/ml, 30 mg/ml or 50 mg/ml) in approximately 430 patients diagnosed with dry eye disease (ded).

protocol axr201701 is designed with 2 stages. for both stages 1 and 2, patients with signs and symptoms of ded will be randomly assigned to receive either a single concentration of axr-159 ophthalmic solution or axr-159 ophthalmic solution vehicle. a screening visit will be followed by a baseline period where subjects will dose with axr-159 ophthalmic solution vehicle for 14 days. at the end of the baseline period patients who still exhibit signs and symptoms of ded will be enrolled into a 3-month double-masked treatment period.

Eligibility criteria:
inclusion criteria: * male or female, 18 years of age or older at screening visit * best-corrected visual acuity (bcva) of 20/100 or better (snellen equivalent), using the logarithm of the minimum angle of resolution (logmar) in each eye * reported history of dry eye for at least 6 months * corneal fluorescein staining score ≥ 2 * eye dryness score ≥ 40 * total ocular surface disease index (osdi) score \> 18 exclusion criteria: * uncontrolled ocular disease (except for dry eye disease/keratoconjunctivitis sicca) or uncontrolled systemic disease * patient has glaucoma, ocular hypertension, on iop-lowering medications or have previously undergone any glaucoma laser or surgical procedure. * corneal abnormality or disorder that impacts normal spreading of the tear film (keratoconus, pterygia, scarring) or compromised corneal integrity * bcva worse than 20/100 in either eye * current use of punctal plugs, anticipated insertion during the study, or a history of punctal cautery in either eye * keratoconjunctivitis sicca secondary to destruction of conjunctival goblet cells * patients with clinically significant inflammation of the lid margin such as anterior blepharitis or ocular rosacea * recent (within the past 3 months) ocular surgery, trauma or herpes * use of contact lenses in either eye within one month prior to the screening visit or anticipated use during the study
evaluate safety and tolerability of pasireotide lar in combination with everolimus in advanced metastatic nets

Conditions: Neuroendocrine Tumors

Summary: this study will evaluate long-term safety and tolerability of pasireotide lar in combination with everolimus in advanced metastatic net patients, who who have not progressed during 12 months of combination therapy with pasireotide lar and everolimus


Eligibility criteria:
inclusion and exclusion criteria: patients eligible for inclusion in this extension study have to meet all of the additional inclusion criteria: * the patient must provide a signed informed consent form (icf) for the extension study prior to any study related procedures * completion of the whole treatment period of 15 months (3 months monotherapy with either pasireotide lar or everolimus followed by a 12 months combination of pasireotide lar/everolimus) in the csom230f2102 study * no tumor progression during 12 months of combination therapy with pasireotide lar and everolimus (checked via radiologically assessment). no intolerable toxicity during combination therapy with pasireotide lar and everolimus
investigating the impact of self-monitoring feedback for health behaviors

Conditions: Obesity

Summary: investigating the impact of self-monitoring feedback for health behaviors

obesity is highly prevalent in samoa, where a 2010 study estimated that 64.6% of adult females were obese, according to polynesian bmi cut offs (bmi ≥32.0 kg/m2).1,2 interventions designed to increase physical activity or facilitate weight loss often include a self-monitoring component, but these intervention programs have not yet been tested in the samoan setting. the goal of this project is to pilot test such an approach. the specific aims of this study are: 1. to investigate the acceptability and feasibility of self-monitoring of physical activity and weight through the introduction of step counting devices (fitbit zips) and scales (bodytrace). 2. to measure any changes that occur in participants' health, health behaviors related to diet and physical activity, or conceptions of health (including self-efficacy and perceptions of weight) over the study period.

Eligibility criteria:
inclusion criteria: * samoan ethnicity (measured by their having four samoan grandparents) * 31.5 - 40 years of age * physically inactive - defined using the world health organization (who) definition of inactivity and the who global physical activity questionnaire * motivated and ready to make behavior changes - defined using the physical activity stages of change framework (contemplation or preparation phase)18 * not pregnant or planning to become pregnant during the 5-week study period - self-reported at baseline * weigh less than 180 kg - based on measured weight at baseline. this restriction is due to the maximum weight of the bodytrace scales used in the intervention. * no medical condition preventing physical activity or making participation inadvisable. these conditions will be measured based on self-report of doctor diagnoses and include: hypertension, heart attack, heart disease, stroke, uncontrolled type 2 diabetes, non-skin cancer diagnosis, dialysis, or a diagnosed eating disorder. participants will also be excluded if they have had significant (\>10 kg) self-reported weight loss in the last 6 months. exclusion criteria: * if participant does not fit the requirements above
loaded gait training on gross motor function in cerebral palsy

Conditions: Cerebral Palsy

Summary: a randomized controlled trial aimed to evaluate the additional effect loaded gait training to conventional physical therapy program on gross motor function and the knee extensors strength in children with bilateral spastic cerebral palsy. children were divided randomly into two equal groups. the control group received a conventional physical therapy program, while the intervention group received the same program plus loaded gait training. gross motor functions and knee extensor strength were measured.

a randomized controlled trial aimed to evaluate the additional effect loaded gait training to conventional physical therapy program on gross motor function and the knee extensors strength in children with bilateral spastic cerebral palsy (cp). 52 children with bilateral spastic cp, aged 5 to 7 years, were divided randomly into two equal groups. the control group received a conventional physical therapy program, while the intervention group received the same program plus loaded gait training 3 times per week for an hour for 3 months. gross motor functions were measured by the gross motor function measure scale-88 (gmfm-88); standing and walking domains, while knee extensor strength was measured by a hand-held dynamometer.

Eligibility criteria:
inclusion criteria: * age: five to seven years old, classified as levels ii and iii on the gmfcs. * spasticity grade from 1+ to 2 based on the modified ashworth scale. * able to understand and follow verbal commands and instructions (with a score above 80 on the stanford binet intelligence scale). exclusion criteria: * genetic or metabolic disorders. * brain tumours. * musculoskeletal dysfunction that would interfere with our intervention (e.g. tightness of the posterior knee joint capsule that causes passive knee extension lag, or fixed contracture of the knee joint). * surgical intervention in the lower limbs within the preceding 12 months. * botulinum toxin injections in lower limb muscles within the last six months.

Keywords: bilateral spastic cp, gross motor function knee extensor strength loaded gait training
pulpotomy vs.root canal treatment in managing irreversible pulpitis

Conditions: Pulpitis - Irreversible

Summary: the study aims to compare two methods of repairing and saving a badly damaged or infected tooth. one method is called root canal treatment (roct) and the other (new method) is called pulpotomy. roct involves removing the damaged area of the tooth including the tooth nerve (called the pulp), cleaning, disinfecting and sealing it. pulpotomy however attempts to preserve as much of the tooth nerve as possible (keeping the tooth alive). roct is more expensive and painful. therefore, some patients delay or avoid getting treated, resulting in later complications treated in an emergency setting. this research will aim to show that pulpotomy is less painful, less involved (i.e. less invasive), less time consuming and consequently more cost effective. long term costs of dental treatment as well as the improved quality of life will therefore offer benefits for patients, public and the nhs who use dental services. caries (tooth decay) is the most common diseases in the world. the nhs spends at least £3.4 billion per year on dental visits or at dental hospitals. this does not include private (societal) costs to individuals who do not qualify for nhs dental treatment. consequently, those who end up avoiding or delaying treatment result in complications often treated through the nhs. we have therefore chosen a randomized controlled trial design, a gold standard method to compare the effectiveness of the two treatment options. the participants will be 168 dental patients (male or female) from different parts (london and liverpool) of the uk so that results can be generalized. this design was considered in consultation with a member of the public (a co-applicant) who will be involved in the trial from the start to completion. the results will be published and discussed at conferences as well as through our patient and public network.


Eligibility criteria:
inclusion criteria: * • dental patients from an acute (secondary care) setting from at least three uk centres (including king's college london dental institute, denmark hill and liverpool). * male or female (aged \>16) able to provide informed consent in otherwise good general health with at least one molar tooth with clinical symptoms of irreversible pulpitis caused by caries, requiring roct (endodontic treatment). * patients enrolled will have clinical symptoms of irreversible pulpitis who need treatment. exclusion criteria: exclusion criteria: * the presence of fistulas or swelling * anterior teeth or premolars * external or internal root resorption * multiple teeth with carious lesions in the same quadrant, * pregnant women, in view of requirements for radiographs. * patients younger than 16. * patients unable to give consent. * patients who have been administered antibiotics in the previous month. * immunocompromised patients * teeth with hopeless prognosis with caries extended into root dentine and with tooth margin at crestal bone level
use of amnion on partial thickness burns

Conditions: Burn

Summary: to determine if amnion, used on partial thickness burn injuries would provide an improvement in rate of healing, pain control and scarring as compared to standard medical treatments.


Eligibility criteria:
inclusion criteria: * partial thickness burn injury. * \>2% burn injury. * ages 0-100 years. exclusion criteria: * patients not expected to survive

Keywords: burn partial thickness burn
rituximab augmentation following r-chop induction chemotherapy in extremely elderly patients with diffuse large b cell lymphoma

Conditions: Lymphoma, Large B-cell, Diffuse

Summary: rituximab (r) plus chop (cyclophosphamide, doxorubicin, vincristine, and prednisolone) combination is considered as the new gold standard for the first-line treatment of elderly patients with diffuse large b-cell lymphoma (dlbcl). the study is aimed to evaluate the overall response rate and the safety of four cycles of r-chop chemotherapy and followed by rituximab augmentation (weekly four times infusion) in newly diagnosed dlbcl patients with aged more than 70 years.

1. four cycles of r-chop chemotherapy for the induction treatment \[dose intensity of chop chemotherapy is modulated according to charlson comorbidity index (cci)\] if patients with cci \<1 * rituximab: 375 mg/m2, day 1 every 3 weeks. * conventional dose of chop chemotherapy repeat every 3 weeks. if patients with cci ≥1 * rituximab: 375 mg/m2, day 1 every 3 weeks. * 75% of conventional chop repeat every 3 weeks. 2. rituximab augmentation * rituximab: 375 mg/m2, every week x 4 times. * trimethoprim-sulfamethoxazole 1 tablet per day during augmentation

Eligibility criteria:
inclusion criteria: 1. histologically confirmed cd20 positive dlbcl 2. age ≥ 70 3. ann arbor stage ii, iii and iv 4. no prior chemotherapy or radiotherapy for dlbcl 5. performance status (eastern cooperative oncology group) ≤ 2 6. at least one or more bidimensionally measurable lesion(s) * ≥ 2 cm by conventional computerized tomography (ct) * ≥ 1 cm by spiral ct * skin lesion (photographs should be taken) ≥ 2 cm * measurable lesion by physical examination ≥ 2 cm 7. cardiac ejection fraction ≥ 50% as measured by echocardiogram without clinically significant abnormalities 8. adequate renal function: serum creatinine level \< 2 mg/dl (177 μmol/l) 9. adequate liver functions: 10. adequate bone marrow functions: hemoglobin ≥ 9 g/dl absolute neutrophil count ≥ 1,500/μl and platelet count ≥ 75,000/μl, unless abnormalities are due to bone marrow involvement by lymphoma 11. life expectancy more than 6 months 12. informed consent exclusion criteria: 1. other subtypes of non-hodgkin's lymphoma 2. patients who transformed follicular lymphoma or other indolent lymphoma 3. primary central nervous system (cns) dlbcl 4. cns involvement by lymphoma or any evidence of spinal cord compression. 5. patients with a known history of human immunodeficiency virus (hiv) seropositivity or hepatitis c virus (+). 6. any other malignancies within the past 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri 7. pregnant or lactating women, women of childbearing potential not employing adequate contraception 8. other serious illness or medical conditions

Keywords: diffuse large b-cell lymphoma elderly patients rituximab augmentation
to assess the efficacy and safety of intravitreal ranibizumab in people with vision loss due to macular edema

Conditions: Macular Edema (ME)

Summary: to evaluate the efficacy and safety of 0.5 mg ranibizumab intravitreal injections in adult patients with visual impairment due to macular edema (me).


Eligibility criteria:
inclusion criteria: * diagnosis of active me secondary to any causes (for adult patients: except diabetic macular edema (dme), age-related macular degeneration (amd) and retinal vein occlusion (rvo)); * bcva must be between ≥ 24 and ≤ 83 letters; * visual loss should be mainly due to the presence of any eligible types of me. exclusion criteria: * women of child-bearing potential, * active malignancies; * history of stroke less than 6 months prior to screening; * uncontrolled systemic inflammation or infection, related directly to the underlying causal disease of me; * active diabetic retinopathy, active ocular/periocular infectious disease or active severe intra-ocular inflammation; * any type of advanced, severe or unstable ocular disease or its reatment; * me with a high likelihood of spontaneous resolution. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: vision impairment
pace-call: a weight control intervention for survivors of childhood leukemia

Conditions: Obesity; Overweight; Weight Loss; Weight Maintenance

Summary: the purpose of this national cancer institute (nci) funded study is to develop and test the acceptability and usability of a web \& text message based weight loss intervention for childhood acute lymphoblastic leukemia (all) survivors. childhood cancer survivors ages 7 - 18 will provide feedback during focus groups on a web and text message based program that was developed.

this is a two year study to develop a predominantly web-based behavioral assessment and intervention program (pace-call) that will provide individual assessment and tailoring of a behavioral intervention for adolescent children acute lymphoblastic leukemia (all) survivors and their families. in addition, we are conducting formative research to adapt the abovementioned program to children and adolescents aged 7 - 18 who survived any cancer. focus groups: web-based \& text message intervention feedback two focus groups will be conducted with adolescent cancer survivors and their families, to assess the usability and acceptability of the web-based intervention, focus groups will be conducted. the two focus groups will last 2 hours with 6-8 people in each group: one focus group with youth \& adolescents (age 7 - 18 who are representative of the target population to determine the appropriateness of the web-based intervention one focus group with the parents of the children in the focus group mentioned above (it will occur at the same time). all focus groups will begin with an overview of the study and description of the web-based intervention components. focus group participants will see sample web pages and may be asked to provide feedback on some or all of the following: youth, adolescent or parent: * how does the web-based and text message based intervention address issues faced by children who have survived cancer? * what do you like about the web-based intervention? what do you not like about the web-based intervention? what would you change about the web-based intervention? * what do you like about the text messages? what do you not like about the text messages? * would you want to join a program like this? why or why not? * if you were to be in this program, how often would you log on to the web-based intervention? how often would you want to receive text messages? * what are some of the barriers to joining a program like this?

Eligibility criteria:
inclusion criteria: * are 7 - 18 years * provide assent and have a legal guardian that will participate and provide parental permission/consent * are a cancer survivor (off treatment for two years) * are overweight or obese (85th percentile bmi (body mass index) for age and gender) exclusion criteria: * have any of the following comorbidities of obesity that require immediate sub-specialist referral including pseudotumor cerebri, sleep apnea, and obesity hypoventilation syndrome

Keywords: weight loss obesity overweight physical activity nutrition youth adolescent technology
an open-label, long-term safety study of linaclotide in patients with chronic constipation or irritable bowel syndrome with constipation

Conditions: Chronic Constipation; Irritable Bowel Syndrome With Constipation

Summary: the objective of this study is to assess the long-term safety of linaclotide administered to patients with chronic constipation (cc) or irritable bowel syndrome with constipation (ibs-c).


Eligibility criteria:
inclusion criteria: * patients must have * entered study lin-md 01\[nct00765882\] or lin-md-31 \[nct00948818\] and at minimum completed the pre-treatment period or * completed one of the following studies: mcp-103-004 \[nct00306748\], mcp-103-005 \[nct00258193\], mcp-103-201 \[nct00402337\], mcp-103-202 \[nct00460811\] * sexually active patients of childbearing potential agree to use birth control * females of childbearing potential must have a negative urine pregnancy test prior to dosing * lactating females must agree not to breastfeed * patient must meet protocol criteria for cc or ibs-c exclusion criteria: * patient must not use protocol-defined prohibited medicine * patient is planning to receive an investigational drug at any time during the study * patient has an unresolved ae or a clinically significant finding on a physical examination, 12-lead ecg, or clinical laboratory test

Keywords: constipation chronic constipation irritable bowel syndrome with constipation linaclotide